Each of the two topics proposed in the call will address one problem of major environmental health relevance: very persistent and mobile chemicals and chemical mixtures. Proposals for innovative solutions to protect our health and the environment from persistent and mobile chemicals are sought as well as new ways to assess and manage risks of chemicals and pharmaceutical mixtures.

Topic 1: Innovative, systemic zero-pollution solutions to protect health, environment and natural resources from persistent and mobile chemicals 

Specific Challenge:

A recent Eurobarometer survey (2020) showed that a large majority of respondents are worried about the impact on their health of chemicals present in everyday products. The European Green Deal includes a commitment to a zero-pollution ambition for a toxic-free environment. In this context, it specifically mentions the need to rapidly address the risks posed by hazardous chemicals and, more specifically, very persistent chemicals.

Pollution from persistent and mobile chemicals is often a systemic problem, as it is driven by factors closely related to the prevailing ways of production and consumption and is reinforced by missing appropriate technical solutions, including (bio)remediation and monitoring techniques for the environment (including the marine environment). These chemicals also pose challenges for regulatory authorities to develop or enforce effective policies.

An example of these chemicals is per- and polyfluoroalkyl substances (PFAS), a group of thousands of manmade chemicals that are widely used in various consumer and industrial products (e.g. water- and stain repellent textiles, fire-fighting foams, food contact materials and cosmetics) and to which citizens are exposed. They are an increasing concern as they are persistent in the environment, very mobile, toxic and can bioaccumulate. For these reasons, they are found everywhere in the environment and their concentration will increase over time, creating additional risks for human health and ecosystems. There are examples of contamination from PFAS of water and soil in most EU countries, which are costly to remediate. The overall costs to society are estimated to be € 52-84bn across Europe, which is likely to be an underestimate, as it includes only a limited range of health effects (high cholesterol, impaired immune system, and cancer). Some studies have shown negative effects of PFAS on the immune system, including a reduced response to vaccines. This is of concern considering the current COVID-19 pandemic.

Scope:

This call topic aims at demonstrating innovative solutions to protect health, environment and natural resources from persistent and mobile chemicals, such as PFAS. Selected projects are expected to advance our knowledge on health impacts and environmental effects and to address a specific pollution problem of contamination of environmental resources (such as soil and drinking water). The solutions should lead to cost-effective mitigation or elimination of the issues (e.g. mitigation or remediation efforts in particularly affected geographic areas), and prevent and better understand negative impacts of the persistent and mobile chemicals on humans and the environment throughout their entire lifecycle. The projects may include appropriate technologies, business, governance and social innovation aspects and cover all innovation deployment phases up to the realisation of innovative solutions in the real life conditions (the first market applications, TRL 7-8). In particular, projects may consider analytical methods, enabling to quantify entire groups of persistent and mobile chemicals such as all PFAS in food or drinking water. This would allow achieving a higher level of consumer protection than regulating individual substances, as such ‘group’ methods are essential for enforcement of the entire group of harmful substances.

The successful projects shall include elements, such as research and development of (bio)remediation technologies of contaminated soil and water for persistent and mobile substances, including sources of drinking water for persistent and mobile chemicals; development of new cost-effective high-resolution methods to measure and separate persistent and mobile chemicals in different media; environmental and human (bio)monitoring of persistent and mobile chemicals; gathering of toxicity and toxico-kinetic information in order to allow characterising all risks to human health, arising from the exposure to the entire group of these substances, including effects on the immune system; development of best practices for the management of waste containing persistent and mobile substances; and detection and identification of specific pollution problems. Proposed solutions should be cost-effective and easily implementable to encourage their uptake. Therefore, close consultation with potential end-users during the project life-time is recommended.

Expected impact:

• Better understanding of emerging and a persistent pollution problem of human and environmental health relevance
• Support the aims of the new Circular Economy Action Plan calling for methodologies to minimise the presence of substances that pose problems to health or the environment  in recycled materials
• Solutions for better (bio)remediation and detection technologies, including real time monitoring approaches
• Improved risk assessment to facilitate optimal risk management
• Harmonisation of hazard and exposure data and databases
• Data of regulatory relevance accessible to policy makers and for risk communication

Type of action: Research and innovation action

Topic 2: Fostering regulatory science to address chemical and pharmaceutical mixtures: from science to evidence-based policies

Specific Challenge:

Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment and several knowledge gaps are identified in EU Strategic Approach to Pharmaceuticals in the Environment.

Humans, wildlife and domestic animals are in general exposed to mixtures of different chemicals via air, water (including the marine environment), food, consumer products, materials and goods. The scientific understanding of mixture effects has progressed in recent years and approaches are available how to better regulate combined exposures to chemicals.

In parallel with the development and implementation of regulatory approaches to better protect human health and the environment from risks of chemical mixtures, there is a need to continuously improve the scientific knowledge base. Current knowledge shows that combined exposures pose risks to ecosystems and human health, and that these risks are not sufficiently managed under existing regulations. Accordingly, there is a need to advance [regulatory] science, thereby providing policy-makers and risk assessors with methods and tools. It is also important to study the effectiveness and efficiency of different policy approaches, and to continue exploring human and environmental exposure to mixtures and associated effects.

Scope:

This topic calls for applied research studies, demonstrating how regulatory science can apply new tools and methodological approaches based on the latest scientific evidence, to quantify and prevent harmful co-exposures to industrial chemicals and pharmaceuticals.  

The applicants can address some or all of the following:

1. Evidence-based solid case studies of which safety margins would actually protect people, including vulnerable groups, and ecosystems, while taking accumulated exposure into account over a longer time scale;
2. Develop and apply modelling, statistical approaches and other relevant methods to study the impacts of chemical mixtures on human populations and the environment, e.g. through linking particular cases identified and effects on the wider population and on ecosystems; 
3. The possible effects on humans of (chronic) exposure to low levels of pharmaceuticals via the environment, taking account of the potential for combined effects from multiple substances, and of vulnerable sub-populations
4. Improvement of models for (chronic) exposure to mixtures, which can be applied in a premarket stage (risk assessment, authorisation and restriction of chemicals), and possibly already at the design phase of chemicals and materials, to predict contribution to combined and overall exposure/risk/toxicity;
5. Validation of models for (chronic) exposure to mixtures through actual testing and sampling;
6. Estimations of the degree to which current regulatory practices/approaches underestimate (or possibly occasionally overestimate) risks related to chemicals exposure (based on particular case studies, modelling and overall estimations);
7. Comparisons of different possible regulatory approaches to manage chemical mixtures with current situation, including regarding effectiveness (improved protection of health and the environment), workability, cost-effective methods and benefits to society and business;
8. Improvement of the knowledge base on mixtures and their health and environmental impact, to underpin and support regulatory action

Expected impact:

• Implementation of existing and new risk assessment and risk management approaches to reduce the most critical exposures, including the setting of limit values and the introduction of new regulatory approaches such as, e.g. Mixture Assessment Factors
• Scientific evidence to enable mitigation of pharmaceutical and other chemicals (mixtures) in the environment

Type of Action: Research and Innovation action

Disclaimer: The presentation of draft topics and the feedback provided shall in under no circumstances bind the European Commission in the final formulation of topics for the call. The binding call text will be published following the formal decision by the European Commission on the Funding and tender opportunities portal. (Source https://ec.europa.eu/)